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Table 1 Characteristics of included trials

From: Investigator initiated trials versus industry sponsored trials - translation of randomized controlled trials into clinical practice (IMPACT)

Characteristics

IIT

Public Germany gov

No. of trials (%)

IIT

Public Germany

other

No. of trials (%)

IIT

Public Germany

(total)

No. of trials (%)

IIT

Public International

No. of trials (%)

IST

Commercial Germany

No. of trials (%)

IST

Commercial International

No. of trials (%)

Total

No. of trials

(%)

Total

60

60

120 (100)

200 (100)

171 (100)

200 (100)

691 (100)

Registered ina

 ClinicalTrials.gov

32 (53)

16 (27)

48 (40)

200 (100)

158 (92)

200 (100)

606 (88)

 DRKSb

14 (23)

48 (80)

62 (52)

–

19 (11)

–

81 (12)

 ISRCTNc

27 (45)

5 (8)

32 (27)

3 (1)

–

–

35 (5)

 EudraCTd

40 (67)

10 (17)

50 (42)

18 (9)

88 (52)

33 (17)

189 (27)

Study status

 Completed

43 (72)

59 (98)

102 (85)

200 (100)

170 (100)

200 (100)

672 (97)

 Prematurely ended

12 (20)

1 (2)

13 (11)

 

1 (< 1)

 

14 (2)

 Still ongoinge

5 (8)

–

5 (4)

   

5 (< 1)

Collaboration

 International

19 (32)

7 (12)

26 (22)

44 (22)

71 (42)

69 (35)

210 (30)

 National

40 (66)

53 (88)

93 (78)

156 (78)

100 (58)

131 (65)

479 (69)

 Unclear

1 (2)

–

1 (< 1)

–

–

–

2 (< 1)

Study size (Median = 150)

  >  150

46 (76)

28 (47)

74 (62)

81 (40)

74 (43)

115 (58)

344 (50)

  ≤ 150

13 (22)

32 (53)

45 (38)

119 (60)

97 (57)

85 (42)

346 (50)

 Unclear

1 (2)

–

1 (< 1)

–

–

–

1 (< 1)

Number of primary outcome(s)

 0

–

–

–

–

1 (1)

–

1 (< 1)

 1

44 (73)

44 (73)

88 (73)

152 (76)

122 (71)

133 (67)

495 (72)

  >  1 (range 2–36)

16 (27)

16 (27)

32 (27)

48 (24)

48 (28)

67 (33)

195 (28)

Study phase drug trialsf

 Total

41 (68)

15 (25)

56 (47)

93 (47)

93 (54)

93 (47)

335 (48)

 2

9 (15)

5 (8)

14 (12)

23 (12)

23 (13)

23 (12)

83 (12)

 3

20 (33)

7 (12)

27 (22)

45 (23)

45 (26)

45 (23)

162 (23)

 4

12 (20)

3 (5)

15 (13)

25 (13)

25 (15)

25 (13)

90 (13)

Study phase non-drug trialsg

 Total

19 (32)

45 (75)

64 (53)

107 (53)

78 (46)

107 (53)

356 (52)

 A

–

9 (15)

9 (7)

15 (7)

11 (7)

15 (7)

50 (7)

 B

16 (27)

33 (55)

49 (41)

82 (41)

43 (25)

82 (41)

256 (37)

 C

3 (5)

3 (5)

6 (5)

10 (5)

24 (14)

10 (5)

50 (7)

  1. a Several trials were registered in more than one trials registry, i.e. numbers do not sum up to the total numbers (100%); bDRKS: German Clinical Trials Register; cISRCTN: International Standard Randomized Controlled Trials Number registry; dEudraCT: European Union Drug Regulating Authorities Clinical Trials Database; eStatus as of 24 April 2020; f15 drug trials of phase 2–3 were counted as phase 2; 24 non-drug trials of phase A-B were counted as phase A; gIn the sub-cohort “Commercial Germany”, we included all non-drug trials available in the study registries, resulting in slightly differing distributions of study phases among the 4 sub-cohorts
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BMC Medical Research Methodology

ISSN: 1471-2288

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